Friday, December 21, 2012

It used to be that the cigarette companies tried to convince the public that their brand - which was slightly different from other brands on the market - was safer than those other brands. Anti-smoking groups pounced on the tobacco companies, arguing that no cigarette was safer than any other cigarette, even though cigarettes differ in terms of ingredients, additives, flavorings, and smoke constituents.

In 1998, Philip Morris introduced Accord, a cigarette that heated rather than burned tobacco. Because of the absence of combustion, the cytotoxicity of the smoke produced was substantially lower than that of conventional cigarettes. Philip Morris was attacked by the anti-smoking groups, which argued that even though the Accord product was completely different in technology, it still delivered tobacco-derived smoke and was therefore just as harmful as the company's other products.

That was in 1998.

When Winston advertised that it contains no additives (without making an
explicit reduced risk claim), R.J. Reynolds was attacked by the
anti-smoking groups, which placed pressure on the FTC. The Commission
eventually forced R.J. Reynolds to put a disclaimer on Winston packages
and advertisements emphasizing that the lack of additives does not
convey any reduction in health risk.

That was in 1999.

The Rest of the Story

In 2012, the Campaign for Tobacco-Free Kids is arguing to the FDA that despite very slight differences in product design, brands of cigarettes that are not identical raise substantially different issues of public health. The Campaign is arguing that despite these very minor differences, cigarette brands that are not identical are substantially different in terms of the public health risk that they pose. Thus, the Campaign argues that such products should not be deemed substantially equivalent.

This is the opposite of the position that the Campaign and other anti-smoking groups have traditionally taken. Previously, when faced with drastic differences in product design (Winston had no additives; Accord involved no combustion), the anti-smoking groups argued that despite these drastic differences, the products were substantially equivalent with regards to the public's health.

Now, all of the sudden, even minor differences render cigarettes substantially different in terms of public health risk.

How did it come to be that major differences in cigarette design used to be of no substantial public health consequence, while today, even minor differences are of substantial public health consequence?

Quite simply, the difference is that in 2009, the Campaign for Tobacco-Free Kids and other anti-smoking groups were successful in convincing Congress to enact the Tobacco Act, and so those groups are now under pressure to make it seem like the Act is going to accomplish something in terms of public health protection. So those groups are trying to convince the public that by strictly regulating very minor changes in cigarettes, the FDA is providing enormous protection to the public's health.

In other words, the Campaign for Tobacco-Free Kids and other anti-smoking groups have reversed their public positions because it is now politically advantageous to make the opposite argument that they made previously.

In an irony of epic proportions, the tobacco companies, in responding to the FDA's proposed guidance on the interpretation of "substantial equivalence," argued that all cigarettes are equally hazardous because all involve the combustion of tobacco and so minor differences in design are not going to render any particular cigarette brand substantially safer than any other brand.

In other words, the tobacco companies adopted the precise argument that the anti-smoking groups used to make.

How ironic that there was a complete, 180-degree reversal in position:

The anti-smoking groups used to insist that even major changes in cigarette design have no appreciable impact on the public health risks of a product. Now, they argue that even minor changes result in substantially different issues of public health risk.

The tobacco companies used to imply that changes in cigarette design rendered a product safer. Now, the companies are telling the truth and acknowledging that minor changes in cigarette design are not going to have any substantial impact on protecting the public's health.

(Note: The arguments provided to the FDA by the Campaign for Tobacco-Free Kids and the tobacco companies are summarized in the following article, which I used as a source for this post: Greenwold ME [senior consultant to the Campaign for Tobacco-Free Kids]. What standards should FDA apply in ruling on applications for substantial equivalence for tobacco products under the Family Smoking Prevention and Tobacco Control Act of 2009? FDLI Food and Drug Policy Forum. Volume 2, Issue 18. September 26, 2012. Washington, DC: The Food and Drug Law Institute.)

Thursday, December 20, 2012

According to the official Tobacco Product Directive released yesterday by the European Union, most electronic cigarettes will be banned and not allowed to enter the market unless and until extensive clinical trials are conducted and the products can be approved as pharmaceutical agents. Only electronic cigarettes with less than 2 mg of nicotine will be allowed. Since most electronic cigarette cartridges contain more than 2 mg of nicotine (and many users report that cartridges below this level are ineffective), this amounts to a de facto ban on electronic cigarettes.

The relevant text from the Directive (Article III, Section 18, Number 1) states as follows:

"The following nicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:
(a) products with a nicotine level exceeding 2 mg per unit, or
(b) products with a nicotine concentration exceeding 4 mg per ml or
(c) products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml."

Since electronic cigarettes were not authorized pursuant to Directive 2001/83/EC, they must be taken off the market and cannot enter the market unless they contain less than 2 mg per unit. Keep in mind that most electronic cigarette users start with cartridges that contain in the vicinity of 12 to 20 mg of nicotine. The implication of this policy is that electronic cigarettes will not remain available as an alternative to cigarettes for smokers who want to reduce their health risks.

The Rest of the Story

There are only two goals I can think of that would logically justify this policy of keeping a much safer alternative to cigarettes out of the possible access of smokers:

1. The goal of punishing smokers for having the desire to undertake the "act" of smoking by making sure that option is not available to them other than the real thing; and

2. The goal of protecting pharmaceutical company profits by insulating them from competition from products that appear to be more effective than anything they currently have on the market.

If the goal were to protect the public's health by doing everything possible to get smokers off of cigarettes, then this policy failed miserably. In fact, it does just the opposite: it helps ensure that smokers will remain on cigarettes and that a significant proportion of them who would otherwise have been able to find an acceptable, safer substitute will no longer be able to do that and will instead remain on cigarettes.

The policy protects cigarette sales and pharmaceutical sales at the expense of the protection of the public's health. Essentially, the policy protects cigarette company and pharmaceutical company profits at the expense of the health of smokers.

The rest of the story is that because of this policy, the substantial decline in cigarette consumption that is predicted for the United States due to the widespread and rapidly growing popularity of electronic cigarettes will not occur in Europe. Now we have to hope that the FDA will not take any further actions to inhibit the ability of smokers to take advantage of this potentially life-saving innovation in the U.S.

Wednesday, December 19, 2012

While many anti-smoking groups and government agencies deny that there is any evidence that electronic cigarettes can be helpful with smoking cessation or reduction, financial analysts now recognize the value of these products, based on overwhelming evidence of their effectiveness: the actual sales data.

In an article in the Winston-Salem Journal, Richard Craver cites financial analysts who predict that electronic cigarettes are so effective smoking cessation/reduction tool that they will put a large dent in cigarette sales, enough to lower tobacco company payments to the states under the Master Settlement Agreement.

According to the article: "The swelling popularity of electronic cigarettes may add to the
regulatory and revenue tension between tobacco manufacturers and states. ... So much so that Herzog said recently in a note to
investors that e-cig sales could grow fast enough to affect the payments
states receive from the landmark Master Settlement Agreement. ...sales of e-cigs are about $300 million a
year and the products have about 2.5 million users, according to Tobacco
Vapor Electronic Cigarette Association. There are projections of $1 billion in annual sales within a few years, Herzog said...".

The Rest of the Story

The anti-smoking groups fail to accept the evidence because they don't want to accept it. They are against electronic cigarettes on ideological grounds, and no amount of scientific evidence is going to get in their way. Not even these sales figures and projections, which demonstrate that smokers are finding these products to be enormously helpful for smoking cessation or reduction - so much so that electronic cigarettes, unlike any previous smoking cessation product, may actually produce a substantial dent in cigarette sales. The reduction in cigarette use is projected to be large enough to actually result in reduced payments to the states under the MSA.

Electronic cigarettes are projected to substantially reduce cigarette sales because they are the first product on the market that addresses both the pharmacologic and physical/behavioral/social aspects of the smoking addiction. It is precisely because the mimic smoking that these products are so widely acceptable among smokers and why they are so effective in substituting for cigarettes.

Ironically, it is precisely because these products mimic smoking that anti-smoking groups can't stand their thought, even though they are demonstrably safer than cigarettes and are literally saving people's lives.

Sadly, the scientific evidence is of little importance in the modern-day anti-smoking movement. Ideology trumps science in the movement in 2012.

Tuesday, December 18, 2012

Tomorrow, the European Commission will present its proposed Tobacco Product Directive. A draft copy obtained by Christopher Snowdon over at Velvet Glove, Iron Fist contains what amounts to a de facto ban on electronic cigarettes, as Christopher reported last week.

Based on the draft copy, Snowdon reports that "nicotine containing products that either have a nicotine level exceeding 2mg, a nicotine
concentration exceeding 4mg per ml or whose intended use results in a
mean maximum peak plasma concentration exceeding 4 mg per ml may be
placed on the market only if they have been authorised as medicinal
products on the basis of their quality, safety and efficacy, and with a
positive risk/benefit balance." Because most electronic cigarettes contain more than 2 mg of nicotine, they would be regulated as medicinal products, which would require companies to conduct a long series of formal clinical trials, costing tens of millions of dollars and taking an average of eight years to complete.

Thus, for all practical purposes, if adopted as apparently drafted, the directive would essentially amount to a ban on electronic cigarettes in the European Union.

The Rest of the Story

It's hard to figure out what the purpose of this aspect of the directive is, but its effect will be to increase tobacco-related disease and death in Europe. If approved as drafted, the directive will prevent smokers from having access to a much safer alternative to cigarettes that has been shown to be effective in helping to keep smokers off of cigarettes, or at least, to cut down significantly on the amount they smoke.

Thus, the effect of this directive would be to protect cigarette sales in Europe at the expense of the public's health.

We can only hope that a more sensible strategy will be substituted for this deadly one once the proposal is fully vetted.

I will provide readers with an update, if necessary, after the directive is officially released tomorrow.

Monday, December 17, 2012

Last Friday, I revealed that the FDA is boasting to the public that it is protecting the public's health by making sure that tobacco companies do not make minor changes to cigarette ingredients, additives, or packaging. According to the FDA's Center for Tobacco Products: "Small changes in ingredients or additives can make a
cigarette more ... harmful."

As I pointed out, this is a dramatic change in its public position, as in the past, the FDA has always maintained that no cigarette on the market is any safer than any other cigarette, as small differences in additives or ingredients between brands do not confer any significant health protection. In fact, the FDA has always maintained that all tobacco products are equivalent in their health effects. Even today, the FDA continues to claim (in contradiction to its statement that small differences in additives make cigarettes more or less hazardous) that: "To date, no tobacco products have been scientifically proven to
reduce risk of tobacco-related disease, or cause less
harm than other tobacco products."
The FDA goes on to assert that anyone who implies that any cigarette brand is safer than any other cigarette brand is committing a "health fraud."

The FDA was joined in this abrupt change in position by the Campaign for Tobacco-Free Kids, which also argued last week that preventing minor changes in cigarette additives or ingredients is essential to protect the public's health.

Today, I found out that one of the foremost tobacco control researchers and advocates - Dr. Stan Glantz - has also abruptly changed positions and is now arguing that by preventing minor changes in cigarette additives, the FDA is serving the public's interest by substantially protecting the health of smokers. On his blog, Dr. Glantz writes: "This is an example of government doing its job to protect the public."

The Rest of the Story

Let's be very clear. Cigarettes are such an extremely hazardous product that minor changes in additives, ingredients, or packaging cannot possibly result in a substantially safer cigarette.

But this is precisely what the FDA, the Campaign for Tobacco-Free Kids, and Dr. Glantz are arguing. Their argument that the FDA is serving an important public health protection function by preventing minor changes in cigarette additives implies that such minor changes are relevant to the harmfulness of cigarettes. That is, they are implying that minor changes in additives can produce a substantially safer cigarette. Because by asserting that minor changes in additives can produce a more dangerous cigarette, the automatic corollary is that minor changes in additives can produce a safer cigarette.

Like the FDA prior to last Friday, and like most of the anti-smoking groups prior to their lobbying for the Tobacco Act, I reject this notion. It is my opinion that the FDA is spending countless time and resources squabbling about nothing. Most of the applications for substantial equivalence designations amount to minor changes that will have no substantial consequences for the health of smokers, and in my view, this effort is largely a waste of time.

Moreover, it diverts attention from where action is urgently needed: in replacing existing cigarettes with alternatives that are actually substantially safer. What is needed are not minor changes but major changes. Of course, one example would be trying to convince smokers to use electronic cigarettes as an alternative to the far more hazardous tobacco cigarettes. But the FDA and many of the same researchers and groups arguing that small changes in additives are critical will not even acknowledge that a major change - completely eliminating the tobacco - is a crucial public health advance.

Most importantly, this change in public position by the FDA and the anti-smoking groups sends exactly the wrong message to smokers. It suggests to smokers that minute differences in cigarette additives and ingredients can produce major changes in the health effects of smoking. This is not only incorrect but it is damaging because it takes the emphasis off the need to quit smoking and gives smokers hope that by merely changing brands, they can substantially lower their risk of disease.

Let's not forget that there are cigarettes on the market that contain no additives. Specifically, Winston cigarettes. In 1999, R.J. Reynolds Tobacco Company was forced by the FTC to change its labeling to indicate that "No additives in our
tobacco does NOT mean a safer cigarette."

However, if the FDA, the Campaign for Tobacco-Free Kids, and Dr. Glantz are correct that additives can increase the toxicity of cigarettes, then R.J. Reynolds was - by definition - initially correct in its implication that the absence of additives confers less health risk. If the FDA's assertion is correct and if it is true that preventing changes in additives protects the public's health, then Winston cigarettes must be safer than cigarettes that contain certain additives. Are the health groups willing to admit this? Or are they bamboozling the public by claiming that the FDA is actually protecting smokers from more harmful products by not allowing additional additives?

The rest of the story is that this change in the anti-smoking groups' position on this issue was stimulated by the Campaign for Tobacco-Free Kids' propaganda campaign in support of the FDA tobacco legislation. The Campaign, in order to convince the anti-smoking groups that the legislation would actually accomplish something in terms of health protection, was able to blind much of the rest of the movement into falling into the previously scorned-upon belief that by regulating additives, the FDA could reduce the health hazards associated with smoking.

To be honest, I don't believe that the FDA is accomplishing any meaningful public health function by disallowing new products that are not precisely identical to existing products. I do not believe for a moment that the public's health would be any more at risk if the FDA took a liberal, rather than strict interpretation of the "substantial equivalence" clause.

In contrast, I do believe that the FDA is harming the public's health by discouraging the use of electronic cigarettes and by adopting a stringent construction of the evidentiary requirements for modified risk product claims.

If the FDA and the anti-smoking groups are being truthful in their claim that cigarette additives make cigarettes substantially more dangerous, are they willing to admit that Winston cigarettes do confer some degree of safety compared to some other cigarettes on the market? If not, then it seems to me that they are talking out of both sides of their mouths.

While existing cigarettes - the most toxic consumer products on the market - continue to kill hundreds of thousands of Americans each year, the Campaign for Tobacco-Free Kids and the FDA continue to obsess about new cigarette introductions, thus creating a fake impression that they are protecting the public's health. In reality, they are doing the opposite: endangering the public's health by ensuring that safer products do not get into smokers' hands.

According to a breaking report from Michael Felberbaum at the Associated Press, the FDA has prevented the tobacco companies from introducing almost any new products in the past 18 months, despite having submitted nearly 3500 applications and although many of these products are almost identical to products already on the market.

Moreover, the Campaign for Tobacco-Free Kids is gravely concerned about a few new cigarette brands that are very similar to existing brands, while doing everything it can to prevent a truly safer product - electronic cigarettes - from taking hold in the market.

According to the article: "They have the burden of demonstrating that new products and product
changes won't increase youth tobacco use, won't increase toxicity and
won't wrongly deter people from quitting," said Matt Myers, president of
the Campaign for Tobacco-Free Kids. The group has raised concerns about new products
that it says were illegally introduced without review by Richmond,
Va.-based Altria Group Inc., parent company of Philip Morris USA, the
nation's largest tobacco company, and No. 2 tobacco maker Reynolds
American Inc. Philip Morris USA's Marlboro Black NXT - a
cigarette that can be switched to menthol by crushing a capsule in the
filter - and two new styles of Reynolds' Pall Mall menthol cigarettes
shouldn't be allowed to be sold without FDA approval, the Campaign for
Tobacco-Free Kids argues. The companies, however, believe they are
complying with federal law. The FDA says it is investigating. It's essential that the FDA move "strongly and
decisively to make public either why these products should be allowed to
be marketed or to get them pulled off the market immediately," Myers
said."

While the Campaign for Tobacco-Free Kids are urging the FDA to pull these new cigarettes off the market, they are not calling on the agency to pull existing brands off the market, and have in fact discouraged the agency from removing existing menthol cigarettes from the market.

The FDA, although working diligently to keep any new cigarettes from being introduced - cigarettes which are virtually identical to existing ones - has done nothing to regulate existing cigarettes to make them any safer.

The Rest of the Story

The rest of the story is that the Tobacco Act is working exactly as I predicted it would: as a way to protect the existing cigarettes on the market and block any real possibility of competition from what could be truly safer products.

While the FDA is obsessing about whether a cigarette with a slight change in its name should be allowed on the market, pretending to be in some way protecting the public health, it has taken no steps to address the lack of safety of existing cigarettes. The FDA has not taken a single action that will make existing cigarettes any safer for smokers. And at the same time, it has done everything it could to prevent a truly safer product - electronic cigarettes - from gaining any foothold in the market, thus protecting the profits of cigarette companies over the health of the public.

It was discouraging to see that Dr. Deyton - the director of FDA's Center for Tobacco Products - embraced the approach of obsessing about minor changes in cigarettes that, an action that does nothing to protect the public's health.

According to the article: "In an interview with the AP, Dr. Lawrence Deyton, director of FDA's
Center for Tobacco Products, said the agency is working with companies
to get more information about products and hopes the industry will be
more transparent about its reasoning that product changes don't affect
public health. Small changes in ingredients or additives can make a
cigarette more addictive or harmful, Deyton said. "Though cigarettes
seem like a very simple product - chopped-up tobacco rolled in paper ...
we know that cigarettes are highly engineered. They're technologically
incredibly sophisticated," said Deyton."

Is the FDA actually suggesting that different brands of cigarettes on the market - each of which contains different ingredients and additives - have different levels of safety? The answer, unfortunately, is yes. This is precisely what it means when you suggest that the agency must monitor for small changes in additives or ingredients because those changes affect the safety of the product in a way that is material to the public's health.

According to this reasoning, the FDA is lying on its web site when it says that no cigarette is any safer than any other cigarette. Clearly, the agency does not believe this is true.

It sends a terribly destructive message to the public: that there are indeed safer brands of cigarettes on the market and that smokers should be concerned about the exact additives and ingredients in their brands.

This is utter nonsense. There is no meaningful difference in the safety profile of any of these cigarettes, as the FDA itself acknowledges on its web site. And to suggest anything else to the public is not only disingenuous but also damaging to the public's appreciation of the dangers of smoking and of the utter futility in trying to protect one's health by switching to one brand of cigarettes over another brand.

The only way to protect oneself by switching tobacco products is to use an entirely different class of products. Case in point: switching from cigarettes to electronic cigarettes would indeed offer tremendous public health benefits.

Sadly, this is the one type of benefit that the FDA is trying to prevent smokers from taking advantage of.

Thursday, December 13, 2012

Last Wednesday, the D.C. Court of Appeals declined to grant an en banc (full panel) review of the Court panel's graphic cigarette warning decision, in which the Court overturned the FDA's graphic warnings on the grounds that the law violates the tobacco companies' First Amendment free speech protections. The FDA will likely appeal this ruling to the Supreme Court.

The Rest of the Story

I think it is quite likely that the Supreme Court will hear this case. Because the warning labels are not purely factual and non-controversial but are designed specifically to create an emotional reaction that is intended to encourage smokers to quit, I believe that the Court will apply intermediate level scrutiny, meaning that it will analyze the constitutionality of the rule under Central Hudson. The key issue will then be whether or not the government has demonstrated that the proposed regulation will substantially advance the government's interest in promoting smoking cessation. This is the critical 3rd prong set out by Central Hudson.

Unfortunately for the government, the FDA's own Regulatory Impact Analysis concludes that there was no statistically significant effect of Canada's graphic cigarette warnings on smoking rates.

The Regulatory Impact Analysis concludes that the predicted effect of the graphic warning
labels is not statistically different from zero: "FDA has had access to
very small data sets, so our effectiveness estimates are in general not
statistically distinguishable from zero; we therefore cannot reject, in a
statistical sense, the possibility that the rule will not change the
U.S. smoking rate. Therefore, the appropriate lower
bound on benefits is zero." (Federal Register 76 at 36776)

It doesn't seem to me that this is the kind of scientific evidence that is going to convince the United States Supreme Court that the proposed regulation will substantially advance the government's interest in lowering adult smoking rates.

Wednesday, December 12, 2012

In a commentary published yesterday on my blog, I criticized a post on Dr. Stan Glantz' blog which embraced the Congressional Budget Office's analysis of the costs to society of an anti-smoking intervention (a 50 cent federal tax increase) due to its saving of lives, thus resulting in more people on the Social Security rolls. Dr. Glantz had taken solace in the fact that the CBO's analysis ultimately found long-term savings to society, while I dismissed the entire approach, arguing that even if the CBO analysis had found that the long-term costs did outweigh the benefits, we should not reject a public health intervention because it will increase Social Security costs by saving lives. I noted that this is a perverse concept and has no place in policy analysis, even if it is ultimately outweighed by benefits of a proposed program. I also pointed out that when Philip Morris set forth the exact same argument in 2001, anti-smoking groups roundly attacked the company, which was forced to apologize and disavow itself from the argument. But rather than disavow himself from this line of reasoning, Dr. Glantz has embraced the approach and went so far as arguing that it sets an example for the analysis of other public health policy issues.

In response to my commentary, Dr. Glantz has attacked me, calling me non-credible as a scientist who is driven purely by ideology and pays no attention to science.

Dr. Glantz writes:

"I normally do not comment on Mike Siegel's blog because he has long
since lost all credibility with me as a scientist. He praises any study
-- no matter how poorly done -- if it supports his ideological position
that he is the one ethical voice in tobacco and trashes any study -- no
matter how well done -- if it does not.
His latest commentary, on my praise for the Congressional Budget Office analysis of the effect of a 50 cent tobacco tax increase (indexed to inflation) on federal spending so seriously misrepresents my position that it warrants response. ... Having a reasonable projection of effects over a long time does
not require that one use that time for policy making. Just to be clear, here is what I think about the ... issue:

The appropriate time horizon for health policy decision making is 10
years, 20 if you really stretch it. (That does not mean that one ought
not try an develop longer-term projections, but decisions should be
based on time horizons over which the projections are most reliable.)
As the CBO notes, the uncertainty in projections grows with time.

Policies to improve health are worth doing even if they cost money.
If society did not accept this position, we would eliminate almost all
medical care, certainly for the elderly or people with serious
disabilities.

The reality is that actual policy decisions are usually made
with very short time horizons, often just months. ... That is why I have put a lot
of energy into estimating the short-term effects of tobacco control policies. ... Urging that 10 to 20 years is the appropriate horizon for health
decisions does not make it invalid to do your best to develop longer
term models."

The Rest of the Story

What troubles me is not that Dr. Glantz accuses me of being completely non-credible and of being a quack scientist. After all, I recently lost all credibility when I appeared on the same page as Khloe Kardashian and Lindsay Lohan in Star Magazine (see the latest issue of Star if you want to see the humbling picture - well, humbling for me and Lindsay, but perhaps not for Khloe).

By the way, my picture appearing within millimeters of Linsday Lohan puts me only 4 degrees of separation from Kevin Bacon, as Lindsay Lohan was in Georgia Rule with Felicity Huffman, Felicity Huffman was in Magnolia with Tom Cruise, and Tom Cruise was in A Few Good Men with Kevin Bacon.

If you're wondering, no - I didn't appear because like Lindsay Lohan I had been arrested - but because I was featured in an "Ask the Expert" column regarding electronic cigarettes.

What does trouble me is that Dr. Glantz fails to respond substantively to my argument, attacks me personally and then diverts the issue.

The issue is: whether it is appropriate to consider as a negative factor in a policy decision the Social Security savings because lives will be saved.

But Dr. Glantz switches the issue to: what is the appropriate time frame for a policy analysis?

But that's not the issue at all. Arguing that a policy analysis should only look 10-20 years down the road is not the same as arguing that a policy analysis should not consider whether saved lives will lead to Social Security savings.

For example, suppose we are analyzing a policy to require insurance coverage for mammograms for women in their 50's. These mammograms will save a considerable number of lives among the screened women and the costs of those saved lives in terms of increased Social Security spending will being to accrue in less than 10 years. This is within the time frame that Dr. Glantz argues is appropriate to consider. Thus, Dr. Glantz is implying that it is perfectly appropriate to consider these costs because they are short-term, not long-term costs.

I disagree. I believe that it is inappropriate to consider these costs at all in making a policy decision, regardless of when they accrue.

It would be valuable to have this discussion. And it is an important issue because the CBO has now legitimized the argument and set an example that may be followed in analysis of a wide range of public health issues. I'm afraid that Dr. Glantz has helped to legitimize the consideration of these costs and I am merely trying to point out the danger of doing so.

My argument hardly seems like such a radical argument that it requires an attack on my credibility (there are plenty of other things on which one could attack my credibility - but this is not one of them!). In fact, my argument is exactly the same one that many anti-smoking organizations made in 2001 in response to Philip Morris' report that counted these costs as a benefit of smoking.

While there are many reasons one could attack my credibility, that I evaluate science based on whether the results support my pre-determined position is not one of them. This attack makes no sense because if it were true, then I would not be criticizing studies that report finding an immediate effect of smoking bans on heart attacks or which find that thirdhand smoke causes massive skin and nerve damage in babies. I have devoted my career to preventing the public from the hazards of secondhand smoke and if I simply judged studies by my ideology, I would be praising all of these studies.

Dr. Glantz is correct about one thing. I am guided by ideology. My ideology is that science is about the pursuit of the truth, and that we have to seek the truth wherever it takes us, even if it sometimes turns out that the truth is not favorable to our advocacy positions. I believe, also, in honesty and transparency and believe that public health practitioners should not deceive the public or distort the science, even if doing so might garner more support for our policies.

And finally, I believe that science is about disagreement and dissent, but that disagreement should garner substantive discussion, not personal attacks on character. The most important advances in science have come from some of the sharpest disagreements. The focus, however, must always be on the science itself - on the arguments and the evidence - not on the personal qualities of those advancing the arguments.

Thus, despite his attacks on me, Dr. Glantz remains a hero of mine. He was my original mentor and teacher and role model in tobacco control and it was his passion, zeal, and ability to develop research that will have the greatest impact on policy that has guided me throughout my career. In many ways, I view Dr. Glantz and another mentor of mine - Dr. Alan Blum - as two of the "fathers" of the anti-smoking movement. One of the things that I admire most about Dr. Glantz is his ability to always be ahead of the rest of the tobacco control movement. Of course, I also admire his willingness to tell it like it is and not be afraid of organizations or politicians and what they might say about him. That quality of Stan's continues to guide me.

Tuesday, December 11, 2012

Dr. Stan Glantz, on his tobacco blog, has written a commentary in which he applauds the Congressional Budget Office's (CBO) analysis of the effect of a 50 cent federal cigarette tax increase on the federal deficit because it finds that although the tax would increase spending for Social Security and Medicare as many lives are saved from smoking cessation, the net savings from reduced health care spending would outweigh these costs.

Dr. Glantz writes: "The Congressional Budget Office just published an important article,
“Cigarette Taxes and the Federal Budget — Report from the CBO,” in the New England Journal of Medicine
on the health and economic effects of a 50 cent increase in the
cigarette tax (which is indexed to increase with inflation). The full
report is available from the Congressional Budget Office here.
It is the most comprehensive and careful analysis of the long-term
fiscal implications of a tobacco control policy I have ever seen. The CBO prepared a sophisticated demographic analysis that includes
people aging into and out of the years that people smoke as well as the
effects of quitting smoking on not only health care costs but also time
in the workforce when people would be paying taxes as well as effects on
living longer. ... As people live longer there would be higher health costs in old age, but
these would be offset by taxes on their increased earnings until about
2060."

In response to concerns that the report considers the savings from people dying earlier and therefore not requiring Social Security or Medicare payments, Glantz writes: "I have received several emails from people expressing concern about this
article because its summary says “By discouraging people from smoking,
the higher excise tax would improve the average health status of the
population … [L]ower health care spending per capita would push down
fderal spending, but increased longevity would have the opposite effect …” [my
emphasis] As noted above, however, this does not mean that the
cigarette tax would have a net effect of raising the federal deficit.
The actual conclusion of the paper is just the opposite: In every year
the federal deficit would be smaller. It is just that in the out years –
after about 2050 -- the net benefit would be less. But there would
still be a benefit."

Dr. Glantz also praises the methodology of the report and argues that it sets an example for analysis of other public health issues: "Another important contribution of this report is that it uses an increased cigarette tax as an example
of a tobacco control policy to illustrate the larger methodology. The
same model could be used to assess the effects on the federal government
for any tobacco control policy. It also provides a strong framework for similar analyses at the state level."

The Rest of the Story

As I explained in an earlier piece, the CBO analysis is one of the most perverse policy analyses that I have ever seen. The authors are actually putting forward the
argument that a major consideration in public health policy should be
the fact that by saving tens of thousands of lives, a policy may result
in increased spending for Social Security and Medicare because people
will live longer.

By embracing this methodology and praising it as a model to be used in other policy evaluations, Dr. Glantz is unfortunately accepting the argument that savings from Social Security and Medicare from premature deaths is a legitimate factor in evaluating public health policies.

As I have argued, can you imagine the same argument being put forward regarding an
analysis of whether the federal government should require health
insurance companies to cover mammography? Would anyone in their right
mind advance the argument that we should not require coverage for
mammography screening because it would save the lives of thousands of
younger women, therefore increasing Social Security spending because
they will now live to be 65, rather than dying in their 40s or 50s and
thus not becoming a drain on the system?

Should we consider that by requiring insurance companies to cover costly
treatments for acute leukemia in children, the federal deficit could be
affected because large numbers of children who otherwise would have
died will now live long enough to enjoy their senior years and have
children and grandchildren of their own?

Sadly, this is precisely the type of argument that Glantz is legitimizing.

The reason why Glantz is not disturbed by this argument: because overall, the CBO analysis came out in support of a tax increase. In other words, this perverse policy analysis is legitimate because it turns out that the cigarette tax resulted in a net benefit in terms of reducing the deficit.

Had the analysis shown the opposite, I would be willing to bet that Dr. Glantz would have criticized the report rather than embracing it. And I'm sure his main line of attack would be the following: How could the authors possibly have considered as a benefit of this policy the fact that thousands of people would live longer and thus be eligible for Social Security benefits? Furthermore, I'm confident that he would have been quick to point out that this strategy was used by Philip Morris in arguing against a cigarette tax increase in the Czech Republic, and that the company disavowed its own report and apologized after being attacked in the international media.

Is Dr. Glantz actually suggesting that it is perfectly appropriate to consider as a factor in public health policy analysis the fact that if we save lives, we are going to end up increasing the deficit because people will live long enough to enjoy Social Security and Medicare benefits? Unfortunately, that's precisely the argument that is implied by his embracing of the CBO report and his condoning of this perverse approach to public health policy analysis.

Suppose a similar policy analysis were to come out unfavorably. Suppose that the CBO analyzed the effects of a program to implement anti-smoking programs in the 50 states and determined that so many lives would be saved that the impact on Social Security and Medicare would be immense. Would Dr. Glantz then argue against that policy? Of course not. The point that seems clear to me is that he is supporting this analytic approach solely because it came out favorably.

This is essentially the new method being used in the anti-smoking movement to judge scientific evidence. If the evidence is favorable to our cause, it is good science. If it's not favorable, then it's junk.

Here is what a number of tobacco control groups and practitioners had to say about the idea of considering the effect of avoiding premature death on lowered Social Security costs in policy analysis when Philip Morris proposed the idea:

Senator Dianne Feinstein: "By including a cost-benefit analysis of human lives in its calculations, PhillipMorris has stepped well-past the lines of decency and demonstrated, once again, that it conducts business in a manner completely disconnected from any sense of right and wrong." Campaign for Tobacco-Free Kids: "Would a responsible, reformed tobacco company tell foreign governments that dead smokers are a good thing for their budgets?"

INFACT: "Even if it were true that smokers dying young would save money for the economy, it's a real scary logic on which to base policy."

Tobacco Products Liability Project: "The governments role normally is to protect the health and safety and
welfare of their citizens so the idea that somehow or another the
government or the state could be benefiting by their citizens dying off
would strike anybody who has their conscious reasonably intact as being
really quite dreadful."

I find it ironic that the anti-smoking movement is now embracing approach that we attacked Philip Morris for taking back in 2001. Eleven years later, what was good for the tobacco industry is good enough for us. When they used the approach, it was despicable because they are bad. But when we use the same approach, it's fine, because we're doing it for a good cause.

Monday, December 10, 2012

A new study published online ahead of print in the journal Indoor Air examined emissions from electronic cigarettes compared to those from regular cigarettes in an experimental chamber. The results demonstrate that electronic cigarettes are much safer than regular ones and that there are likely only minimal health risks associated with exposure to secondhand vapor.

In the experiment, a smoker puffed on an electronic cigarette with one of three types of liquids, or on a regular tobacco cigarette in a sealed chamber while measurements were made of various volatile organic compounds. In subsequent tests, exhaled air from an electronic cigarette user was directly sampled and tested for volatile organic compounds.

The study found that the chief components of the gas phase were propylene glycol, glycerine, nicotine, and flavorings.

The levels of volatile organic compounds during vaping were substantially lower than during smoking. Most of the chemicals detected during smoking were not detected during vaping. The only chemical of significant concern was formaldehyde, but the levels were low -- only 14% of that produced during smoking.

During direct testing of the electronic cigarette vapor (produced by a pump), no formaldehyde was detected.

The Rest of the Story

The results of this study are consistent with those of previous studies which have examined the components of electronic cigarette vapor or investigated the gas phase components produced during the experimental use of electronic cigarettes. Other than the potential effects of respiratory irritation from long-term inhalation of propylene glycol, the main concern appears to be the presence of formaldehyde. However, in this study, formaldehyde levels in the experimental chamber were low and formaldehyde was not detected in the actively sampled electronic cigarette vapor. The most striking finding of the study was the relative safety of electronic cigarette vapor compared to tobacco smoke.

This study confirms that electronic cigarette use is much safer than smoking and suggests that any health risks associated with passive exposure to electronic cigarette vapor are likely to be quite low.

Further studies are necessary to better understand the exact effects that long-term inhalation of propylene glycol may have on the lung and to better characterize the exposure to formaldehyde that may occur from "active" or "passive" vaping. But there is no question that any risks associated with electronic cigarettes are dwarfed by those caused by smoking and secondhand smoke exposure. Thus, electronic cigarettes are a viable alternative to cigarettes that drastically reduce health risks.

In my opinion, electronic cigarette companies which are claiming that use of their products reduces the health risks associated with cigarette smoking are making factual statements for which there is plentiful scientific evidence. As the FDA is currently considering regulations for electronic cigarettes, it is my hope that the agency will not apply section 911 (the modified risk provisions) to these products -- or at least not apply the regulatory framework established in that section. If strictly applied, section 911 would preclude electronic cigarette companies from arguing that these products are safer than regular cigarettes. This would essentially force companies to withhold the truth from consumers and would not serve the public interest.

This study is a death knell for the claims of anti-smoking researchers such as Dr. Ellen Hahn, who have argued that there is no evidence that electronic cigarette use is any safer than smoking.

Remember that as I reported back in August, an article published in the March issue of the journal Nursing Clinics of North America claimed that
there is no scientific basis to argue that cigarettes are any more
harmful than non-tobacco-containing electronic cigarettes that merely
vaporize nicotine from a solution containing nicotine, glycerin, and
propylene glycol. These authors assert that despite the
fact that electronic cigarettes contain no tobacco and involve no
combustion, produce no smoke, and do not contain most of the tens of
thousands of chemicals and more than 60 known carcinogens in tobacco smoke, there is no scientific basis to
claim that tobacco cigarettes are any more harmful than electronic
ones.
The article stated that: "no scientific basis currently exists for making claims of ... reduced harm ... for e-cigarettes."

This study adds to a body of scientific evidence that destroys the validity of that argument. It is now clear that electronic cigarettes are reduced harm products (compared to conventional cigarettes). Anyone who continues to claim that there is no scientific basis for such a claim is either lying or living in a secluded cave without internet access.

Friday, December 07, 2012

In BBC Newsarticle about electronic cigarettes, anti-smoking advocates from three leading national tobacco control organizations are misleading the public into thinking that vaping is a form of smoking and that electronic cigarette use is essentially the acceptance of, and adoption of smoking.

According to the article, here are the reactions of three of the leading national tobacco control organizations to the emergence and skyrocketing growth of the electronic cigarette market:

The Campaign for Tobacco-Free Kids

"Since their emergence onto the US market, US sales have risen from
$5m (£3.1m) to an estimated $250m, according to UBS estimates. Amid the explosive growth, smoking opponents are eyeing the devices warily. 'We know that smoke-free laws encourage smokers to try to quit,' says
Danny McGoldrick, vice-president of research at Campaign for
Tobacco-Free Kids. If electronic cigarettes keep people smoking who would otherwise quit, that is harmful, he says." ...

Americans for Nonsmokers' Rights

"'It feels like what they're trying to do is re-establish a norm that
smoking is okay, that smoking is glamorous and acceptable,' says Cynthia
Hallett, executive director of Americans for Non-Smokers' Rights."

American Legacy Foundation

"The blu advert stokes the spirit of rebellion that appealed to
smokers when they first started as adolescents, says David Abrams,
executive director of the Schroeder Institute for Tobacco Research and
Policy Studies at Legacy, an anti-tobacco organisation. This time around, instead of defying parents and teachers,
the ad encourages smokers to rebel against more recent anti-smoking
social norms. 'They're capitalising on that with adult smokers by basically saying 'don't let society tell you what to do',' Abrams says. 'You have the freedom to smoke. Thumb your nose at the anti-smoking policies and the FDA.'"

The Rest of the Story

What
all three of these national tobacco control organizations apparently
fail to understand is that using electronic cigarettes is not smoking.
On the contrary, it is avoiding the use of cigarettes. The overwhelming reason why smokers are turning to electronic cigarettes is because they want to reduce or eliminate the number of cigarettes that they smoke. Every time a vaper uses an electronic cigarette, he or she is passing up an opportunity to smoke. By definition, using electronic cigarette use reduces cigarette use. Far from promoting smoking, advertisements that promote electronic cigarette use are urging smokers not to smoke -- but to switch to electronic cigarettes instead.

In fact, the emergence and growth of electronic cigarettes is not a boon to cigarette smoking, it is a serious threat. To successfully market electronic cigarettes, companies need to get smokers to switch away from smoking and towards vaping. Electronic cigarettes are primarily designed for smoking cessation or cigarette use reduction. In the first clinical trial of these products, 54% of smokers who were unmotivated to quit were successful in either quitting smoking completely or cutting down on their smoking by more than half.

In exactly what way does the Campaign for Tobacco-Free Kids, Americans for Nonsmokers' Rights, and American Legacy Foundation consider this tremendous reduction in smoking to be a rebellion against the idea of not smoking and an encouragement of smokers to continue to smoke.

Nothing could be further from the truth. It's exactly the opposite of what each of these three organizations is saying.

How could these organizations be lying to the public in such a blatant manner?

The answer appears to be ideology.

Each of these three anti-smoking organizations appears to be blinded by an ideology that defines smoking as going through the hand motions associated with holding and smoking a cigarette, regardless of whether the person is actually smoking. Apparently, even if the person has quit smoking completely, she is still smoking if she goes through the hand motions.

Are these organizations really committed to saving lives, or are they just trying to prevent hand motions? Sadly, it appears that it is the hand motions that are bothering them. We can't have those hand motions going on that look like smoking. Even if those hand motions are saving hundreds of lives by getting smokers off of a product that may well kill them.

Thursday, December 06, 2012

Earlier this year, I discussed a study which casts doubt on the effectiveness of nicotine replacement therapy (NRT) in smoking cessation. The study, published in the journal Tobacco Control,
challenges the prevailing wisdom in the tobacco control movement by
arguing that NRT is ineffective for
smoking cessation and that therefore, public expenditures for NRT
provision to smokers is a waste of resources. The researchers found no difference in relapse rate among
those who used NRT for more than six weeks, with or without
professional counseling. No difference in quitting success with use of
NRT was found for either heavy or light smokers. The authors concluded that: "using NRT is no more effective in helping people stop
smoking cigarettes in the long-term than trying to quit on one's own."

In response, the president of the Association for the Treatment of Tobacco Use and Dependence (ATTUD) - Dr. Michael Steinberg - issued a public statement denouncing the study and defending NRT. According to the statement: "ATTUD does not believe this study shows that NRT doesn't help smokers to quit. This is not a groundbreaking study, but just one of 11 case-control studies on NRT, many of which have found efficacy, while others have not. Unfortunately many reputable news agencies ran the press-release of the article without examining the findings. We fear that the consequences may be that many people who very much need to quit smoking and would benefit significantly from NRT will not use it because they now believe that NRT does not work. We would encourage clinicians, the media, health administrators, etc. to read the article and compare our interpretation of the findings with those of the authors. Falsely concluding that a proven treatment is ineffective can be tragic, especially when the targeted disorder is the leading cause of preventable death in the world."

The Rest of the Story

What Dr. Steinberg does not reveal in ATTUD's public statement is that he has a financial conflict of interest by virtue of his financial relationship with a pharmaceutical company that manufactures a smoking cessation drug, and thus stands to lose financially if pharmacotherapy is found to be ineffective (or less effective than currently believed) for smoking cessation.

From an article published in 2010, we find out that Dr. Steinberg has had a financial relationship with Pfizer: "Dr. Steinberg’s institution received a grant from Pfizer for research support for a clinical trial, and he has received payment from Pfizer for the development of educational presentations."

And from a 2008 article, we find out that Dr. Steinberg has received grant support from Pfizer, has consulted for Big Pharma, and has received honoraria from Pfizer.

A Business Weekarticle published in 2008 criticized Dr. Steinberg for failing to disclose his financial interest in Pfizer to patients that he treats with the drug and for failing to disclose this conflict on his university web site page. (The article incorrectly states that the financial conflict was not accessible from the journal's web site, but I found that was not the case: without purchasing the article, I was able to view the financial conflict of interest disclosure statement.)

I believe that this financial conflict of interest should have been revealed in the public statement responding to the Alpert and Biener study. Because of this conflict, ATTUD's interpretation of the study is inherently biased, and the public deserves to know about this conflict so that they can make an informed judgment about the validity of ATTUD's arguments.

This is not the first time ATTUD has failed to disclose a personal financial conflict of interest in a public statement. In 2009, ATTUD wrote a letter to the FDA urging that the agency remove electronic cigarettes from the market. However, the letter failed to reveal the financial conflicts of interest of its two co-authors with Big Pharma. These authors had financial relationships with pharmaceutical companies that
manufacture nicotine replacement products and stand to lose out in a
major way if electronic cigarettes become popular.

I wrote at that time: "The rest of the story is that ATTUD appears more concerned with serving
the interests of its own practitioners, who largely depend upon
pharmaceutical money and traditional pharmaceutical-based smoking
cessation programs for their livelihood than with serving the interests
of smokers and of the public's health. This has the appearance of
an organization which is sacrificing the public's health in order to
protect Big Pharma profits, motivated by a bias created by a significant
financial conflict of interest with the pharmaceutical companies. I
believe it is unethical for a "health" organization like ATTUD to try
to influence public policy with a press release and letter to the FDA
without disclosing these significant financial conflicts of interest."

In a 2011 letter to the FDA, ATTUD again failed to disclose the financial conflicts of interest of its president at the time, who signed the letter. This letter was an attempt to influence public policy by lobbying the agency to give more favorable treatment to smoking cessation medications. The conflict of interest was therefore quite relevant to the petition and it should have been revealed.

ATTUD again failed to disclose the financial conflict of interest of its president at the time in a 2011 letter to the head of the Department of Public Welfare in Pennsylvania, urging him to give favorable treatment to smoking cessation drugs in terms of the state's decision on whether to include access to these medications as Medicaid benefits.

In yet another 2011 letter, this one to the Joint Commission, ATTUD hides the conflict of interest with Big Pharma of its president at the time, despite urging the Joint Commission to release standards that would require hospitals to prescribe a smoking cessation drug to every smoker, unless specifically contraindicated.

ATTUD also failed to reveal financial conflicts of interest of its leadership with Big Pharma in its 2010 citizen's petition to the FDA, which requested special favorable treatment in the review of smoking cessation medications -- treatment that is not given to other drugs reviewed by the agency.

To make matters worse, it appears that ATTUD is failing to disclose its own institutional conflict of interest with Big Pharma on its web site and in all of its public statements and letters attempting to influence public policy. In none of these statements or letters do I see it revealed that ATTUD has received financial support from Big Pharma. However, ATTUD has received financial support from GlaxoSmithKline.

Unfortunately, it does not look like ATTUD has learned its lesson. Sadly, it appears that the organization is still putting the financial interests of its own practitioners over the interests of smokers and the public's health. And it continues to hide the fact that its president has a financial relationship with a company that manufacturers smoking cessation drugs, thus undermining the organization's objectivity. Furthermore, it is also hiding from the public the fact that the organization itself has received money from Big Pharma. There is no way for readers to know the truth unless they search for the rest of the story.

Wednesday, December 05, 2012

In an article published at About.com, Dr. Lynne Eldridge offers an intriguing argument that there has been too much of a focus on the role of smoking in the lung cancer epidemic and that anti-smoking programs can only prevent a small fraction (20%) of lung cancer cases.

Dr. Eldridge writes: "As Lung Cancer Awareness Month draws to a close I'm glowing from
hearing about all of the events - and how each year there are more and
more advocates investing their precious time and energy to spread
awareness and provide funding for lung cancer research. But amidst that
glow is a sadness. It seems just when I get excited about a new
organization or another medical institution promoting awareness, I read
the second line. "The key to reducing lung cancer deaths is to launch
more anti-smoking campaigns." Yes, those campaigns are important. But if we want to reduce lung
cancer deaths, anti-smoking campaigns just aren't going to do it. Or
even come close." ...

"Nearly 80% of people diagnosed with lung cancer now, in 2012, are non-smokers. All of the anti-smoking campaigns imaginable are not going to make a difference for this 80%. Maybe a few numbers will make it even clearer. In 2008, the last year
from which we have numbers available, there were 158,592 deaths from
lung cancer in the United States, including 70,051 deaths in women.
(Note that in the same year, there were 40,589 breast cancer deaths in
women.) Using the 80% statistic, 126,874 of these deaths could not have
been prevented by anti-smoking campaigns.
So why are we focusing on anti-smoking campaigns? Why are we focusing
our attention on only 20% of people who develop lung cancer?"

The Rest of the Story

There is a very good reason why we are focusing our attention on the role of smoking in lung cancer. It's because smoking is the cause of approximately 80% of all lung cancer cases. Therefore, smoking is the number one preventable cause of lung cancer, and it dwarfs all other preventable causes. Focusing on the role of smoking in lung cancer makes perfect sense and to act otherwise would be irresponsible.

There is a major fallacy in Dr. Eldridge's argument. She argues that because only 20% of lung cancer cases occur among smokers, only these 20% of lung cancer cases could be prevented by anti-smoking programs. This is untrue. Among the 80% of lung cancer cases that occur among nonsmokers, the overwhelming majority - at least 75% - are attributable to smoking. These cases occur among former smokers. By hiding the fact that these lung cancer patients had a history of smoking is actually undermining the public's appreciation of the link between smoking and lung cancer. While these former smokers quit before they were diagnosed with lung cancer, it hardly means that their lung cancers were not attributable to their smoking, or that their lung cancers could not have been prevented had they not been smokers in the first place.

In fact, if anti-smoking programs were fully successful in preventing smoking, we would prevent 80% of lung cancer. According to Dr. Eldridge's argument, an 80% reduction would not represent even "coming close" to reducing lung cancer deaths.

Actually, the truth is that smoking is the number one preventable cause of lung cancer, and therefore, preventing smoking is the single most important intervention that could have the greatest impact on reducing lung cancer deaths.

I completely agree with Dr. Eldridge that anti-smoking programs alone are not the only intervention that is necessary to reduce lung cancer deaths, that attention needs to be paid to other preventable causes of lung cancer (especially radon and arsenic), and that much more money needs to be allocated to research into more effective treatments for lung cancer. However, advocating for these three causes does not necessitate undermining the well-established connection between smoking and lung cancer, nor does it justify misleading the public into thinking that only 20% - as opposed to 80% - of lung cancer cases are attributable to smoking.

I think we can be honest with the public and faithful to the basic public health science which has established smoking as the leading preventable cause of lung cancer while at the same time advocating for more attention and resources to radon and arsenic and to research into lung cancer treatment. Why the need to cut off our nose to spite our face?

The study examined 20 brands of electronic cigarettes, and analyzed the contents of their cartridges for nicotine, propylene glycol, glycerin, polycyclic aromatic hydrocarbons, and tobacco-specific nitrosamines.

The results were reported in the study abstract as follows: "Varying nicotine amounts were found in ENDS cartridges which were labelled with the same concentration. Chemicals such as PPG and glycerol were found to be present in the nicotine-containing liquid of the cartridges. ENDS varied in their contents and packaging information. Limited information was available on the contents of nicotine and other chemicals present in a variety of ENDS sampled."

The paper concludes as follows:

"While the current attention on traditional tobacco products is important, it is also necessary to focus on novelty products like ENDS, which may encourage maintenance of tobacco usage behaviour and slow down the impact of national smoking control programmes. Tobacco control policy makers and professionals are seriously urged to find ways to address the gap in the scientific understanding and the legal framework of such products, as this gap may impede efforts at curbing tobacco use."

The Rest of the Story

If you read the introduction, methods, and results of this study, and then proceed to the discussion, you will be shocked and you might think you are reading the discussion to a different study. This is because the discussion has very little relevance to the actual findings in the paper.

First, while the discussion section focuses on what the authors claim are serious health effects associated with electronic cigarettes, the paper's results actually found that there were no detectable polycyclic aromatic hydrocarbons or tobacco-specific nitrosamines in any of the 20 brands of electronic cigarettes tested, providing powerful evidence that these products are much safer than tobacco cigarettes. Curiously, this latter finding is not reported or addressed in the paper's abstract or discussion section. It is almost as if the authors are intent upon only reporting the risks of electronic cigarette use, but not the potential benefits.

Second, while the discussion section warns users about the finding of high levels of propylene glycol and glycerin in the cartridges, it fails to inform readers that propylene glycol and glycerin are the excipients used to vaporize the nicotine. They are indeed the ingredients of the cartridges, so their presence in high levels in the cartridges is not of concern.

Third, while the paper's abstract implies that the mislabeling of nicotine content is a safety concern, the truth is that this is solely an efficacy concern. In fact, the lack of consistency in nicotine delivery likely makes electronic cigarettes less addictive than regular ones.

But most importantly, the paper's conclusion - that electronic cigarette use promotes the maintenance of tobacco use - literally comes out of nowhere. There is nothing in the results or findings of this paper which provides evidence that electronic cigarette use promotes the maintenance of tobacco use. Nor does the paper cite any evidence whatsoever that electronic cigarette use promotes the maintenance of tobacco use.

It appears that the authors have simply made up this conclusion, making it appear out of thin air. This again suggests that the point of this paper was not simply to report the scientific findings, but to make a pre-ordained statement against electronic cigarette use.

In fact, it is counter-intuitive to conclude that electronic cigarette use would promote tobacco use. By definition, the use of electronic cigarettes is an alternative or substitute to cigarettes. Thus, the more electronic cigarettes are used, the less tobacco cigarettes are smoked. The majority of smoker who use electronic cigarettes are doing so because they want to reduce or eliminate their cigarette smoking. Far from promoting tobacco use, electronic cigarettes are devices designed to reduce cigarette use. Furthermore, there is abundant evidence that electronic cigarette use has accomplished exactly that: reducing tobacco use among smokers.

The only two ways in which electronic cigarette use could promote tobacco use would be: (1) if they encouraged youth (nonsmokers) to use nicotine and then to become smokers; or (2) if they caused users to smoke more.

The second hypothesis is absurd and there is abundant evidence that contradicts that notion. As far as the first hypothesis goes, there is no evidence to support it.

The rest of the story is that this is apparently another electronic cigarette smear job by anti-smoking researchers who cannot tolerate the idea that something which looks like a cigarette could possibly be helpful in reducing cigarette use.

Perhaps the most telling statement in the paper is this one: "Due to its odourless and smokeless delivery system, the e-cigarette can be used in non-smoking areas, as suggested by some ENDS product inserts. This has the potential to allow people to satisfy the smoking urge despite being in areas where smoking is prohibited."

To an objective observer, this would be seen as a tremendous benefit of electronic cigarettes. By satisfying the smoking urge in the face of increasing smoking bans, these products can help smokers refrain from smoking. Without the products, addicted smokers would be forced to go outside and light up a cigarette to satisfy their cravings. But with the advent of electronic cigarettes, they can satisfy that urge without the use of tobacco.

It certainly seems that the anti-smoking movement is out to get electronic cigarettes - a product they cannot tolerate because it simulates smoking. But their simulation of smoking is precisely why electronic cigarettes are such a promising strategy for the wide-scale promotion of smoking cessation.

Monday, December 03, 2012

Last week, the D.C. federal district court approved corrective statements that the cigarette companies must make - on cigarette package inserts and public advertisements - as one of the remedies in the Department of Justice's RICO case against the tobacco industry. These statements are intended to correct past statements of the industry that disseminated false or misleading information to the public.

Today, the Rest of the Story is announcing that it has approved a series of corrective statements for the federal government. These statements are intended to correct false or misleading statements that the government is currently disseminating to the public.

First, here are the corrective statements that Judge Kessler approved:

A. Adverse Health Effects of Smoking

A Federal Court has ruled that the Defendant tobacco companies deliberately deceived the American public about the health effects of smoking, and has ordered those companies to make this statement. Here is the truth:

• Smoking kills, on average, 1200 Americans. Every day.

• More people die every year from smoking than from murder, AIDS, suicide, drugs, car crashes, and alcohol, combined.

• Smoking also causes reduced fertility, low birth weight in newborns, and cancer of the cervix and uterus.

B. Addictiveness of Smoking and Nicotine

A Federal Court has ruled that the Defendant tobacco companies deliberately deceived the American public about the addictiveness of smoking and nicotine, and has ordered those companies to make this statement.
Here is the truth:

• Smoking is highly addictive. Nicotine is the addictive drug in tobacco.

A Federal Court has ruled that the Defendant tobacco companies deliberately deceived the American public by falsely selling and advertising low tar and light cigarettes as less harmful than regular cigarettes, and has ordered those companies to make this statement. Here is the truth:

• Many smokers switch to low tar and light cigarettes rather than quitting because they think low tar and light cigarettes are less harmful. They are not.

• "Low tar" and filtered cigarette smokers inhale essentially the same amount of tar and nicotine as they would from regular cigarettes.

A Federal Court has ruled that the Defendant tobacco companies deliberately deceived the American public about designing cigarettes to enhance the delivery of nicotine, and has ordered those companies to make this statement. Here is the truth:

• Defendant tobacco companies intentionally designed cigarettes to make them more addictive.

• Cigarette companies control the impact and delivery of nicotine in many ways, including designing filters and selecting cigarette paper to maximize the ingestion of nicotine, adding ammonia to make the cigarette taste less harsh, and controlling the physical and chemical make-up of the tobacco blend.

• When you smoke, the nicotine actually changes the brain - that's why quitting is so hard.

E. Adverse Health Effects of Exposure to Secondhand Smoke

A Federal Court has ruled that the Defendant tobacco companies deliberately deceived the American public about the health effects of secondhand smoke, and has ordered those companies to make this statement. Here is the truth:

• Secondhand smoke kills over 3,000 Americans each year.

• Secondhand smoke causes lung cancer and coronary heart disease in adults who do not smoke.

Here are the corrective statements that The Rest of the Story has approved:

A. Serious Adverse Side Effects of Chantix

The Rest of the Story has ruled that the Department of Health and Human Services is deceiving the American public about the potentially fatal side effects of the smoking cessation drug Chantix, and has ordered the Department to make this statement. Here is the truth:

• The Department of Health and Human Services is intentionally deceiving the public by hiding the fact that Chantix use has been associated with hundreds of completed suicides and suicide attempts, not merely with suicidal ideation. On our smoking cessation page and detailed Chantix information page, we stated that "There have been rare reports of mood swings, depression and suicidal thoughts." However, we neglected to tell you that there have been hundreds of reported cases of actual suicides and suicide attempts.

• There are now at least 200 lawsuits that have been filed by the
families of plaintiffs who allege that their loved ones committed
suicide as a result of taking the smoking cessation drug Chantix
(varenicline) or by plaintiffs who attempted suicide after starting
Chantix. These cases were filed by a single law firm, which is
investigating another 1,200 cases. Another firm is investigating 175
similar cases.

• We also failed to inform you that the use of Chantix by pilots, air traffic controllers, and commercial drivers has been banned.

• The Institute for Safe Medication Practices stated that: "We have immediate safety concerns about the use of varenicline
(Chantix) among persons operating aircraft, trains, buses and other
vehicles, or in other settings where a lapse in alertness or motor
control could lead to massive, serious injury."

The Rest of the Story has ruled that the Department of Health and Human Services is lying to the American public about the nature of the evidence that electronic cigarettes can be helpful in smoking cessation, and has ordered the Department to make this statement. Here is the truth:

• We lied to you when we told you that "there is no evidence" that electronic cigarettes can help someone quit smoking.

• A clinical trial in Italy found that even among smokers unmotivated to quit smoking, 54% either quit completely or cut down on the amount they smoked by more than half.

• There is abundant anecdotal and survey evidence that electronic cigarettes have helped many smokers to quit.

C. The Presence of Carcinogens in Electronic Cigarettes

The Rest of the Story has ruled that the Food and Drug Administration (FDA) is deceiving the American public about its laboratory findings
regarding the detection of carcinogens in electronic cigarettes, and has ordered the FDA to make this statement. Here is the truth:

• We told
you that electronic cigarettes contain carcinogens but we deceived you
by not revealing the level and by not comparing it to that of regular
cigarettes or nicotine replacement products.

• We
found only trace levels of tobacco-specific nitrosamines in electronic
cigarettes, comparable to those found in FDA-approved nicotine
replacement products like nicotine patches and nicotine gum.

• The
levels of carcinogens we detected in electronic cigarettes are orders
of magnitude lower than in regular cigarettes, indicating that
electronic cigarettes are likely much safer than regular cigarettes in
terms of cancer risk.

• The minute levels of tobacco-specific
nitrosamines in electronic cigarettes are a necessary result of the
extraction of nicotine from tobacco. Overall, these devices deliver
nicotine with only a few other chemicals, compared to the delivery of
nicotine plus tens of thousands of chemicals and more than 60 proven
carcinogens in regular cigarettes.

D. The Cardiovascular Effects of Brief Secondhand Smoke Exposure

The Rest of the Story has ruled
that the United States Surgeon General is deceiving the American
public about the acute effects of brief exposure to secondhand smoke, and has
ordered the Surgeon General to make this statement. Here is the truth:

• We
deceived the American people by telling you that even a single, brief exposure to
secondhand smoke is enough to cause atherosclerosis and heart disease.

• The truth is that it takes many years of tobacco smoke exposure to develop atherosclerosis and heart disease, even among active smokers.

• You cannot develop heart disease from just a single, brief exposure to secondhand smoke.

• We also deceived the American public by telling you that a brief exposure to secondhand smoke can cause you to develop cancer.

• The truth is that there is no evidence that a single puff on a cigarette is sufficient to
cause cancer, and we are not aware of any specific cases in which this
has occurred. We are also not aware of any cases in which a single, transient exposure to secondhand smoke has resulted in cancer.

• Cancer risk among those exposed to secondhand
smoke is linearly related to the overall amount of lifetime exposure.E. Flavored Cigarettes as a Gateway to Addiction Among Youth

The Rest of the Story has ruled that the Department of Health and Human Services and the Food and Drug Administration are deceiving the public by stating that flavored cigarettes are a gateway to life-long addiction
and that the removal of flavored cigarettes from the market will greatly reduce the problem of cigarette smoking among youth, and has ordered us to make this statement. Here's the truth:

• At the time they were banned, flavored cigarettes made up less than 0.1% of the youth market.

• Taking the few remaining flavored cigarette brands off the market had no appreciable effect on youth smoking.

• It
is the non-flavored brands - the Marlboros, Camels, and Newports -
which are responsible for almost all youth addiction to cigarettes.

• The
only flavoring that is significantly contributing to youth addiction -
menthol - is the one flavoring which has been exempted from our ban on flavored cigarettes.

Thursday, November 29, 2012

A commentary published yesterday in the New England Journal of Medicine argues against a federal cigarette tax increase because it would save so many lives that tens of thousands of people would live longer, resulting in increased Social Security and Medicare payments years later.

The authors, from the Congressional Budget Office (CBO), estimate the effects of a 50 cent per pack increase in the federal cigarette tax on the federal budget over a 70-year period. They find that while health care spending would substantially decrease, this effect would eventually be offset by increases in Social Security and Medicare spending because tens of thousands of people would live longer and thus be eligible for these programs.

The authors conclude that: "By 2035, some 63,000 additional adults would be alive because of the
higher cigarette tax. And by 2085 (the final year of the analysis), more
than 3 million adults would be nonsmokers because of the policy,
including about 200,000 who would otherwise have died earlier."

However, they also find that: "The reduction in federal outlays would total $730 million over the
period between 2013 and 2021. During the second decade, however, the
effects on longevity would begin to dominate and federal spending would
be higher than it would have been otherwise — an effect that would
continue through 2085. The two principal drivers of that increase in
spending would be Social Security and Medicare. Improvements in
longevity from a reduction in smoking tend to have their greatest effect
on the size of the elderly population and thus tend to boost spending
on programs aimed at that population."

The Rest of the Story

This is one of the most perverse policy analyses that I have ever seen, and it is certainly the most perverse one that I have ever seen published in a medical journal. The authors are actually putting forward the argument that a major consideration in public health policy should be the fact that by saving tens of thousands of lives, a policy may result in increased spending for Social Security and Medicare because people will live longer.

Can you imagine the same argument being put forward regarding an analysis of whether the federal government should require health insurance companies to cover mammography? Would anyone in their right mind advance the argument that we should not require coverage for mammography screening because it would save the lives of thousands of younger women, therefore increasing Social Security spending because they will now live to be 65, rather than dying in their 40s or 50s and thus not becoming a drain on the system?

Should we consider that by requiring insurance companies to cover costly treatments for acute leukemia in children, the federal deficit could be affected because large numbers of children who otherwise would have died will now live long enough to enjoy their senior years and having children and grandchildren of their own?

Should policy makers consider that by instituting flu clinics for senior citizens they may be saving tens of thousands of lives per year, and therefore increasing Social Security and Medicare costs from what they would have been if these seniors contracted the flu and pneumonia and died off?

The fiscal effects of prolonged life on future Social Security and Medicare payments is simply not an appropriate criterion upon which to evaluate public health policies. Decisions about funding Social Security and Medicare must be kept separate from decisions about interventions to improve the public's health. If a public health program results in saving lives and people living longer, than it is the government's responsibility to find methods to raise the revenue necessary to provide Social Security and Medicare payments when these people reach age 65. The decisions must be kept separate.

Interestingly, one does not see the CBO or other groups advancing this same argument for other issues, such as mammography. The argument is almost always reserved for tobacco policies. In fact, the argument was developed by the tobacco industry, which in 2001, advanced the argument that smoking in the Czech Republic had net economic benefits for the economy because smokers die earlier. The report was attacked internationally, forcing Philip Morris to disavow the report and apologize.

The rest of the story is that it is despicable that the Congressional Budget Office believes that it is appropriate to evaluate a public health policy based on whether it might save lives and therefore increase Social Security and Medicare spending. In doing so, the CBO is borrowing a page right out of the tobacco industry's playbook. This type of analysis would never be done for an issue such as mammography, because anyone who advanced such an argument would be raked over the coals.

Like Philip Morris, the CBO should disavow its report and apologize for the argument it advances.

Finally, while it is shameful that the CBO has advanced this argument, it is also shameful that the journal agreed to publish this argument, thus giving it legitimacy. Both the CBO and the journal owe readers and the public an apology.

Wednesday, November 28, 2012

A new study published online ahead of print in the journal Tobacco Control reports measurements of particulate and nicotine levels in cars with smoking occurring. Based on these measurements, the study concludes that secondhand smoke exposure in cars makes up as much as 30% of tobacco smoke exposure for children and that banning smoking in cars with children would dramatically reduce illness.

The methods of the study were as followed: "SHS exposures in stationary vehicles with two different window configurations were monitored. A volunteer smoked three cigarettes
in a one-hour period for twenty-two experiments. PM2.5, CO, nicotine and PAH where measured in the backseat of the vehicle."

The results were as follows: "We estimate that a child spending only ten minutes in
the car with a smoker at the mean PM2.5 concentration measured in the first window configuration −1697 mg/m3 – will cause a 30% increase to the daily mean PM2.5 personal average of a child."

The study concludes: "Reducing SHS exposures in a vehicle would substantially reduce personal exposure for both children and adults. Particularly in the case of children, measures to reduce or eliminate SHS exposure in vehicles could have a major impact in reducing the risks of SHS-related illness.

The Rest of the Story

There is a significant flaw in the article which renders its conclusion questionable.

The article makes an assumption that is not explicitly stated. The assumption is that smokers who smoke in cars in the presence of their children do not smoke in the home. This is not only a questionable assumption, but it is most likely incorrect.

A parent who smokes in the enclosed environment of a car with his or her child present is most likely not going to refrain from smoking in his or her own home. Chances are that the child is exposed to secondhand smoke not only in the car, but in the home as well.

Since the study assumed that no smoking takes place in the home (it used measurements taken from smoke-free homes in estimating the increased exposure attributable to tobacco smoke exposure in the car), it has grossly overestimated the true fraction of tobacco smoke exposure due to the car compared to the home.

In fact, if one uses the same levels of particulate matter and nicotine as were found in cars in this study and estimates the proportion of overall tobacco smoke exposure for children who live in a home with a smoker, one realizes that the percentage of exposure from the car is only about 2% to 10% of the child's total secondhand smoke exposure.

Although the concentration of secondhand smoke in cars is very high, the duration of exposure in the car is much lower than in the home. Dose is equal to concentration multiplied by duration. Because the duration of exposure in the home is so much greater than in the car, the dose received in the home dwarfs that from the car.

The rest of the story is that for a child exposed to tobacco smoke in a car, that exposure probably accounts for only 2% to 10% of his or her overall tobacco smoke exposure. Between 90% and 98% of that child's exposure to tobacco smoke occurs in the home. For this reason, banning smoking in cars is going to slightly reduce the child's secondhand smoke exposure, but it is unlikely to cause a major reduction in health effects because the child is still heavily exposed to tobacco smoke in the home. A reduction of 2% to 10% is unlikely to substantially reduce the risk of illness due to secondhand smoke.

If anti-smoking advocates want to protect children from the health effects of secondhand smoke, and they feel that banning smoking in private cars is justified, then why are they not also calling on laws to ban smoking in homes with smokers?

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.